QA Process and Cleaning Validation Senior Specialist
Gdańsk
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities
- Serving as Subject Mater expert for Cleaning and Process Validation according to cGMP and FDA requirements;
- Review and approve validation documentation and provide guidance to site staff on cGxP requirements for cleaning and process validation;
- Performing and approving the GxP risk and impact assessments ;
- Approving Deviations, CAPAs and Change controls related to Process and Cleaning Validation;
- Conducting activities in accordance with the applicable cGMP, FDA CFR 21 Part 11 and internal procedures;
- Collaborate with Production, MS&T, Engineering and other business units, contractors and vendor resources to ensure successful planning, execution and delivery of validation projects and documentation deliverables.
If you have
- Higher directional education (Chemistry, Biotechnology or technical related fields);
- Possess working knowledge of global GxP regulations (GMP, 21 CFR Part 11, Data Integrity);
- Knowledge and understanding of latest industry data integrity trends, lifecycle management for cleaning and process validation;
- Minimum 3-5 years of experience in pharmaceutical industry with knowledge about cleaning and process validation;
- Ability to recognize and solve problems independently, good organization and presentation skills, ability to work efficiently under time pressure;
- Strong change control and root cause analysis experience;
- Experience in creation/maintenance & implementation of SOPs;
- Must be well-organized and a team player;
- Must be detail oriented, with strong analytical and problem-solving skills, and to effectively research, troubleshoot, and solve challenging problems involving integrated systems;
- Fluent English;
- Flexibility, communication skills, teamwork spirit.